A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorArrowhead Pharmaceuticals
About this trial
This is a Phase 1/2a double-blind dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of ARO-ALK7 in adult participants with obesity without Type 2 Diabetes Mellitus (T2DM) (Part 1), and the safety, tolerability, and PD of multiple doses of ARO-ALK7 in adult participants with obesity with and without T2DM, either as monotherapy or in combination with tirzepatide (Part 2).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Obesity, defined as body mass index (BMI) between 30-50 kilograms (kg)/square meter (m²), inclusive, with weight at Screening not to exceed 159 kg (350 pounds [lbs])
At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification
No abnormal finding of clinical relevance at Screening that could adversely impact participant safety during the study or adversely impact study results
Female participants of childbearing potential must agree to use highly effective contraception and male participants with female partners of childbearing potential must agree to use a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later. Participants must not donate sperm or eggs during the study for at least 90 days following the end of the study or last dose of study drug, whichever is later
Disqualifiers
Self-reported (or documented) weight gain or loss >5% within 3 months prior to Screening
Use of glucagon-like peptide-1 receptor agonist (GLP-1RAs) (liraglutide, semaglutide, etc.) for any indication within 6 months prior to Screening
Use of non-GLP-1R medications for weight loss within 3 months prior to Screening, including but not limited to naltrexone/bupropion, orlistat, phentermine/topiramate, and other prescription or over-the-counter medication or supplement taken for weight loss purposes
Obesity attributable primarily in the Investigator's opinion to medication use, monogenic or endocrinologic disorders (other than polycystic ovary syndrome)
Trial design
Design model
Parallel
Treatments tested in this trial
ARO-ALK7
DrugSubcutaneous (SC) injection
Placebo
Drugcalculated volume to match active treatment by SC injection
Treatment groups
150 Participants
are divided into 4 treatment groupsGroup A: Part 1 and Part 2 (optional cohort): ARO-ALK7Experimental treatment 1 intervention
Group B: Part 1 and Part 2 (optional cohort): PlaceboPlacebo comparator 1 intervention
Group C: Part:2: ARO-ALK7 + TirzepatideExperimental treatment 1 intervention
Group D: Part 2: Placebo + TirzepatidePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame
Up to Day 253 End of Study (EOS)Secondary outcomes
1
Pharmacokinetics (PK) of ARO-ALK7 (Part 1 Only): Maximum Observed Plasma Concentration (Cmax)
Time frame
Through 48 hours post-dose2
PK of ARO-ALK7 (Part 1 Only): Time to Maximum Observed Plasma Concentration (Tmax)
Time frame
Through 48 hours post-dose3
PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)
Time frame
Through 48 hours post-dose4
PK of ARO-ALK7 (Part 1 Only): Area Under the Plasma Concentration Versus Time Curve from Zero to the Last Quantifiable Plasma Concentration (AUC0-t)
Time frame
Through 48 hours post-doseSponsors and contacts
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Source ClinicalTrials.gov